K09 1978RESPONSE TO FDA LErrER DATED SEPTEMBER 4, 2009 Page 1 of 10

NIKKJSO CO., LTD

Section 6- 510(k) Summary MAR 2 5Zl

a. Company name, addressNIKKISO CO.; LTD.Medical Equipment Unit498-1 Shizutani, Makinohara-shiShizuoka, 421-0496, Japan

b. ContactHachiro EdamuraManager of Quality Control

c. Date preparedJune 19, 2009

d. Name of device.Trade Name: DBB-06 HEMmo~ALYSIS DELIVERY SYSTEMCommon Name: High Permeability HemnodialyzerClassification Name: Dialyzer, High Permeability With or Without Sealed Dialysate System

e. Predicate devicesThe DBB-06 HEMODIALYsis DELIVERY SYSTEM is substantially equivalent to:

510(k): K023509Trade name: DBB-05 Hemodialysis Delivery SystemProduct code: KDI

510(k): K061519Trade name: Modification to DBB-05 Hemodialysis Delivery SystemProduct code: KDI

f. Description of the deviceThe DBB-06 HEmODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for thedelivery of dialysate and extracorporeal blood circuitry. The permeate is heated anddeaerated in the hydraulic section, which is then mixed with concentrate and fed into thedialyzer through the dialysate fluid feeder. The closed balancing system assures the amountof dialysate infused corresponds to the amount of dialysate extracted. The interior pressureof the dialyzer is controlled automatically by adjustment of the ultra filtration amount andUF rate by the dialyzer. Heparinization of the external circulating blood is accomplishedwith the heparin pump either by continuous or bolus injection before it is passed on to thedialyzer.

DBB-06 HEMODIA-LYSIS DELIvERY SYSTEM SECTION 6(K(091978) 6-2OF 6-11

ATTACHMENT QUESTION 1, 2, and 3

K09 1978RESPONSE TO PDA LETTER DATED SEPTEMBER 4, 2009 Page 2 of 10

NIKKISO CO., LTD

The DBB-06 HEmoDIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonatedialysis. Utilizing the various functions of the device, the conductivity and UF profile canbe programmed. In addition, the device incorporates all fuinctions necessary fordouble-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit iscleaned and disinfected using selectable cleaning programs and is equipped with protectivesystems for patient safety and proper operation.

A Blood Volume Monitor (BVM) is an optional accessory available for the DBB-06H.EmQDIIYis DELIVERY SYSTEM, and was not available with the predicate device, theDBB-05 Hemodialysis Delivery System. The BVM monitors blood volume to assist in theprevention of excessive removal of fluid.

g. Indications for Use

Indication for UseThe DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed byphysicians for adult patients with acute and chronic renal failure, treated in hospitals anddialysis clinics by qualified operators. The DBB-06 Hemnodialysis Delivery System is notindicated for pediatric patients. It is not for home use.

h. Statement of substantial equivalenceThe DBB-06 HEmODiALYSIS DELIVERY SYSTtM is substantially equivalent to the DBB-05Hemodialysis Delivery System (1(023509) and the Modification to DBB-05 HemodialysisDelivery System (KO061519).

Table 1 below compares the DBB-06 HEMODIALYSis DELIVERY SYSTEM to the DBB-05Hemnodialysis Delivery System (K(023509) and the Modification to DBB-05 HemodialysisDelivery System (KO061519). All three devices are totally self-contained machines andinclude:

* the samne Indication for Use* use the same Operating Principle* incorporhte the same Basic System Design* automatic priming of the extracorporeal circuit* prepare dialysate*•monitors for the dialysate and blood* pumps for blood and anticoagulant (heparin) at predetermined rates*•controls fluid removal* automatically cleans, disinfects, and rinses the dialysate flow path* incorporate the same materials

DBH-06 HEMODIALYsIs DELivERY SYSTEM SECTION 6(K091978) 6-3 OF 6-11

ATT1ACHMENT QUESTION 1, 2, and 3

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RESPONSE TO FDA LElTER DATEE) SEPTEMBER 4, 2009 Page 6oflO0NIKKISO CO., LTD

New optional accessories

Blood Volume Monitor (BVM')A Blood Volume Monitor (BVM) is a new optional accessory available with the DBB-06HEMODIALYSTs DELIVERY SYSTEM, which was not available in the predicate devices; theDBB-05 Hemnodialysis Delivery System (K(023509) and the Modification to DBB-05Hemnodialysis Delivery System (K061519).

The predicate device used to determine substantial equivalence to the Blood VolumeMonitor (BVM) was the CHIT-LINE Monitor III (CLMIII (K(972470). Both the BloodVolume Monitor (BVM) and the CHIT-LINE Monitor HII (CLMIII) (K(972470) are identicalin function and operate under the same principle of light absorption passing through theblood under test, to measure hemnatocrit and calculate the related value of blood volume.

Following is comparison table for the Blood Volume Monitor of DBB-06 and theCHIT-LINE Monitor III (K(972470);

Table 2 BVM Compariso Table _____________

-, ~~~~~~~~~~~~~~~~~~~~~~~ *~~~~~~~~~~I

Intended Use Used for non-invasive hematocrit, Used for non-invasive bloodoxygen saturation and blood volume volume monitoring. This monitoringmonitoring. Percent change in blood provides the percent change involume in real time application in the blood volume in real time. Thetreatment of dialysis patients with healthcare provider may increase orintended purpose of providing a more decrease the rate at which fluid iseffective treatment for the dialysis removed from the blood based onpatient. Based on the data that the the data that blood volume monitormonitors provide, the dialysis provides.technician increases or decreases therate at which fluid is removed fromthe blood in order to remove themaximum amount of fluid from thedialysis patient without the patientexperiencing the common symptomsof dialysis which include nausea,

_________________cramping and vomiting. ______________

Technological V-,-$r,

Principle of blood The device functions and operates The device functions and operatesvolume monitoring under the principles of light under the principles of light

absorption through the blood to absorption through the blood tocalculate the relative value of Blood calculate the relative value of BloodVolume (BV). Volume (BV).

Microprocessor YesYecontrol

DBB-06 HEMODLALYSis DELIVERY SYSTEM SECTION 6(K091978) 6-7 OF 6-11

ATTACHMENT QUESTION 1, 2, and 3.

K09 1978

RESPONSE TO FDA LETITER DATED SEPTEMBER 4, 2009 Pg fINTKKISO CO., LTD

The measurement is Yes Yesaccomplished bycalibrated Analog toDigital Converters(ADC).Accuracy Approximately +/-2% and compare Approximately +/-2% and compare

well with other methods such as well with -other methods such ascentrifuge. centrifge.

Clinical testing No clinical testing was performed. Clinical Test was performedComparison testing was performed onblood bank blood under simulated

_____ ____ ____ ____ conditions.

Based on the technical characteristics, performance and failure simulation testing of theBlood Volume Monitor (BVM), NIKKISO CO., LTD. concludes that the Blood VolumeMonitor (BVM) performed as well as and is substantially equivalent to the CRIT-LINEMonitor mI (CLMIH (1K972470) and does not raise any new questions regarding safety oreffectiveness.

Non-Invasive Blood Pressure CNIBP) measurement moduleA Non-Invasive Blood Pressure (NIBP) measurement module is an optional accessory usedto monitor the patient's blood pressure during hemodialysis treatment. The DBB-05Hemodialysis Delivery System (K023509) and the Modification to DBB-05 HemodialysisDelivery System (K061519) both use the Omron Colin Model M2100 NIBP. The DBB-06HEMODIALYSIS DELIVERY SYSTEM uses a newer model, the Omron Colin ModelM2500 NIBP. The manufacturer for both models is Omron Colin Co., Ltd., 1-12-14Koishikawa, Bunkyo-ku, Tokyo Japan.

The M2500 is integrated into a variety of patient monitors worldwide and is used to measurepatient blood pressure using the oscillometric method with a standard blood pressure cuffwrapped on the patient's upper arm. The M2500 consists of the following four majorhardware and software blocks:

* Cuff pressure control hardware block* Cuff pressure detection and pulse detection hardware block* Cuff pressure and pulse amplitude data set generation block* Blood pressure determination block

The M2 100 was developed using similar technology of the predicate device, the Press-MateAdvantage (K(973637). All three (3) NIBPs, the M2500, M2100 and the Press-MateAdvantage are manufactured by Cohin Corporation, which merged with Omron Groupcreating the new company Omron Cohin Co., Ltd.

DBB-06 HEMOWALYsis DELIVERY SYSTEM SECTION 6(K091978) 6-SoF 6-ll1

ATTACHMENT QUESTION 1, 2, and 3

K09 1978RESPONSE TO FDA LETTER DATED SEPTEMBER 4, 2009 Page 8ofl10

NaIKISO CO., LTD

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Foblloin3i comparison table of the M2500, M2100 and the Press-Mate Advantage.

Table 3 coparison tble of th M500, M100 and te Press-M teo, Adatae

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~ h.~*A 'IiO~rl$im;;7MpI cuff 12-40c~~~m Sam NIB0fo6DH6Ocm

2 Cuf Bicomatiblit Comsf-aplicant CompTan Complian3~ga KIEC6001.-30199 Compliat Complant IC601601-~t2430:199

2 Cuff0ioco- ati1lit Compliant Compliant Compliant

5 ENI060-3:1997 Compliant Compliant Compliant6 ANSTIAAMI SF-la Compliant Compliant Compliant

for NIBP Measurement7 Measuring range and C) to 300mmH 0 to 300mmH 0 to 300mmli

Accuracy Within +I-3mmHg Within +/-3mmlHg Within +/-3mm g8 Power supply DC 12V DC 12 V9 Pin assigns 3 Signal Pins and 7 3 Signal Pins and 7 ~

Power supply pins Power supply pins10 Technical Alarms 12 types of alarms 12 types of alarms 12 types of alarms

_______________________ (C II -2 1) (CII-21) (C 11-2 1)I1I Fatal Alarms 4 types of alanns(E03, 4 types of 4 types of alanns(E03,

E07, EOS,E09) alanns(E03, E07, E07, E08,E09)____ ___ ___ ___ ___ __ _ ___ ___ ___ ___ ___ E 0 8 ,E 09) _ _ _ _ _ _ _ _ _ _ _

12 Software algorithms Same Same Same*: Device is an all-in-one vital signs monitor with NIBP, and is not connected to another

device.

DBB-06 HEMODL4LYSis DELIVERY SYSTEM SECTION 6(1K091978) 6-9 OF 6-11

ATTACHMENT QUESTION 1, 2, and 3

K09 1978RESPONSE TO FDA LETrER DATED SEPTEMBER 4, 2009 Page 9 of 10

'N ~~~~~~~~~~~~~~~~~~~~~~~NIKKISO CO., LTD

As shown in the above comparison table as well as in the performance test in those bloodpressure monitors, it is demonstrated that M2500 is substantially equivalent to the M2 100 usedin the predicate devices, the DBB-05 Hemnodialysis Delivery System (K023509) and theModification to DBB-05 Hemodialysis Delivery System (KO061519) and to. Press-MateAdvantage, and does not raise any new questions regarding safety or effectiveness.

DBB-06 HEMODiAIYSIS DELIVERY SYSTEM SECTION 6(K(091978) 6-1l0OoF6-11

ATTACHMENT QUESTION 1, 2, and 3

K09 1978

RESPONSE TO FDA LEflER DATED SEPTEMBER 4, 2009Pae1of0NIKKISO CO., LTD

i. ConclusionBased on the above discussion and enclosed sections regarding substantial equivalence topredicate devices, NIKKISO CO., LTD. concludes that the DBB-06 HEmODIALYSISDELIvERY SYSTEM is substantially equivalent to the DBB-05 Hemnodialysis Delivety System(k023509) and the Modification to DBB-05 Hemodialysis Delivery System (k061519), anddoes not raise any new questions regarding safety or effectiveness.

DBB-06 H-EMODIALYSis DELivERY SYSTEM SECTION 6(K091978) 6-11 OF 6-11

ATTACHMENT QUESTION 1, 2, and 3

~DEARTENATOFH EALTH &HUMAN SERVICES

Food and Drug Admuinistration10903 New Hamipshire AvenueDocument Mail Center - W066-G609Silver Sprin~g, MD 20993-0002

Nikkiso Co., Ltd.% Fumiaki Kanai, Ph.D.President and CEOMIC International4-1-17 H-ongo Bunkyo-kLuTokyo, 1 13-0035JAPAN

MAR 2 5 2010

Re: K091978Trade/Device Name: DBB-06 Hemodialysis Delivery SystemRegulation Number: 21 CFR §876.5860Regulation Name: High permeability hemodialysis systemRegulatory Class: 11Product Codes: KDIDated: March 19, 201 0Received: March 22, 2010

Dear Dr. Kanai:

We have reviewed your Section 5 10(k) Oremarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premnarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PIVIA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Relzister.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You must complywith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related

Page 2 -

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product

radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please

go tohttp:H/www.fda. gov/AboutFDA/Ce~ntersOffices/CDRHI/CDRHOffices/ucm 15 809.htm for

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please

note the regulation entitled, "Misbranding by reference to premnarket notification" (21CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go tohttp://www.fda. gov/MedicalDevices/SafetyLRep~ortaProblern/default.htrin for the CDRH' s Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Conisumer Assistance at its toll-free number

(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda. 2 ov/MedicalDevices/ResourcesforYou/InfdustrV/default.htm.

ctin Diec r, Division of Reproductive,Adominal, and Radiological Devices

ffice of Device Evaluation.Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k)Number(Ifknown): •' 7

Device Name: DBB-06 HEMODIALYSIS SYSTEM

Indication for UseThe DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed byphysicians for adult patients with acute and chronic renal failure, treated in hospitals anddialysis clinics by qualified operators.The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is notfor home use.

Prescription Use X AND/OR Over-the Counter Use ___

(Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

nurneof CDRH, Office of Device Evaluation (ODE)

(DivisionSirfDivision of Reproductive, Abdominal, andRadiological Devices510(k) Numnber_ 0 Ke iq-7ig k[

ATTACHMENT Q'UESINON 1, 2, and 3